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Pfizer

Crizotinib (Xalkori) Expanded Access Protocol For The Treatment Of Adult Or Pediatric Patients

Official Title: 
CRIZOTINIB (XALKORI(REGISTERED)) EXPANDED ACCESS PROTOCOL FOR THE TREATMENT OF ADULT OR PEDIATRIC PATIENTS WITH SOLID OR HEMATOLOGIC MALIGNANCIES THAT HARBOR A CRIZOTINIB-SENSITIVE MOLECULAR ALTERATION BUT WHO ARE UNABLE TO SWALLOW CRIZOTINIB CAPSULES
Brief Summary: 
This is an open label expanded access protocol for the treatment of up to approximately 40 adult or pediatric (defined as age <18 years) patients with tumors harboring either a chromosomal translocation or activating mutation involving the ALK or ROS1 gene or an activating genetic alteration involving the cMET gene who cannot swallow the crizotinib capsule but may be able to derive benefit from treatment with an alternative oral formulation of crizotinib.
Detailed Description: 

Crizotinib is indicated in the U.S. for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. Commercially available dosage forms are 250 mg and 200 mg capsules. This expanded access protocol (EAP) is designed to provide access to an alternative oral formulation of crizotinib for those patients who are unable to swallow capsules.

Available
EA Type
Individual Patients
Neoplasm

Drug: Crizotinib
For adult patients, crizotinib 250 mg BID will be administered orally at approximately the same time each day on a continuous daily dosing schedule, ie, without break in dosing. For pediatric patients, crizotinib 280 mg/m2 BID will be administered orally at approximately the same time each day on a continuous daily dosing schedule, ie, without break in dosing.
Other Name: XALKORI

Eligibility Criteria: 

Inclusion Criteria:

- Histologically or cytologically proven diagnosis of a primary or metastatic malignancy that is positive for a chromosomal translocation or activating mutation involving the ALK or ROS1 gene or an activating genetic alteration involving the c MET gene, as determined by local clinical testing that is appropriately validated in accordance with applicable regulatory guidelines and/or practice standards (patients with tumors harbouring other genetic alterations that may potentially benefit from treatment with crizotinib eg NTRK3 ETV6 fusion gene may be considered on a case by case basis subject to approval by the sponsor).

- Inability to swallow crizotinib capsules, adult patients of whom must either have a feeding tube in place or have completed clinical evaluation of dysphagia without any reversible causes identified.

- At least 12 months of age (patients <12 months of age will be evaluated on a case by case basis and discussed with the sponsor).

Exclusion Criteria:

- Currently receiving crizotinib, another ALK inhibitor, or an investigational product.

- Adult patients who have been previously treated with crizotinib.

Eligibility Gender: 
All
Countries: 
United States
Locations: 

Children's Hospital Colorado
Aurora, Colorado, 80045

Children's Healthcare of Atlanta
Atlanta, Georgia, 30322

Children's Healthcare of Atlanta
Atlanta, Georgia, 30342

Boston Children's Hospital
Boston, Massachusetts, 02215

Dana-Farber Cancer Institute
Boston, Massachusetts, 02215

West Chester Medical Center
Hawthorne, New York, 10532

Cohen Children's Medical Center
New Hyde Park, New York, 11040

New York Medical College
Valhalla, New York, 10595

Westchester Medical Center/Maria Fareri Children's Hospital
Valhalla, New York, 10595

Children's Hospital of Philadelphia (Investigational Pharmacy)
Philadelphia, Pennsylvania, 19104

Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104

St. Jude Children's Research Hospital
Memphis, Tennessee, 38105

Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226

Medical College of Wisconsin
Milwaukee, Wisconsin, 53226

Contacts: 

Pfizer CT.gov Call Center
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com

Pfizer CT.gov Call Center
Study Director
Pfizer

EA Number: 
Keywords: 
chromosomal rearrangement, activating mutation, activating genetic alteration, genetic aberration, ALK, ROS1, cMET, crizotinib, Oral formulation
MeSH Terms: 
Crizotinib
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